Boehringer, Lilly get US green light for delayed diabetes drug

Boehringer Ingelheim and Eli Lilly have finally secured approval for its diabetes drug Jardiance in the US after a several months delay.

The US Food and Drug Administration (FDA) cleared Jardiance (empagliflozin) as an addition to diet and exercise to improve glycaemic control in adults with type 2 diabetes, more than four months after delaying a decision because of quality deficiencies at the Boehringer facility where it is made.

Boehringer was sent a warning letter by the FDA over the Good Manufacturing Practice (GMP) deviations at the plant in May 2013, specifically relating to particulate contamination in products made there, but the company confirmed in June that these had been resolved.

The drug’s safety and effectiveness were evaluated in seven clinical trials with 4,480 patients which showed that Jardiance improved haemoglobin A1c levels (a measure of blood sugar control over time) compared to placebo, said the FDA.

Jardiance was approved in Europe in May but is bringing up the rear among leaders in the new class of SGLT2 inhibitors for diabetes, lagging behind rivals Forxiga (dapagliflozin) from AstraZeneca, Johnson & Johnson’s Invokana (canagliflozin) and Astellas/Kotobuki’s Suglat (ipragliflozin).

Forxiga won the race to market in Europe, Invokana was first in the US and Suglat took pole position in Japan.

While the DPP-4 inhibitor class headed by Merck & Co’s Januvia (sitagliptin) is expected to remain the biggest category in type 2 diabetes therapies in the coming years – with a current market share of 40 per cent – the SGLT2 inhibitors are also expected to become blockbusters. Along with other drugs such as once-weekly GLP-1 agonists like Eli Lilly’s dulaglutide, the class will whittle away that share to around 25 per cent by 2022, according to figures from Datamonitor.

It predicts that uptake of the SGLT2 inhibitors will increase even when the DPP-4 inhibitors start to lose patent protection in 2021, thanks to their novel mechanism of action – which means they act independently of insulin – as well as their ability to help diabetics reduce weight. By 2022 the class as a whole will achieve sales of around $7.5 billion in the US, Japan and five largest EU markets, it predicts.

Boehringer and Lilly are also working on fixed dose combinations of Jardiance with metformin and the two companies’ DPP-4 inhibitor Trajenta (linagliptin).